Rates Of Early Adverse Events Research Articles

Open Retrograde Stenting of Proximal Innominate and Common Carotid Artery Stenosis.

The evidence regarding the treatment of open retrograde stenting of innominate artery (IA) or common carotid artery stenosis (CCA) is limited, and is suspected to carry a high risk of stroke and death. Therefore, the objective of this study was to evaluate the outcomes of such hybrid procedures. A retrospective, monocentric study of all patients who underwent retrograde stenting of proximal IA and CCA stenosis via surgical cutdown of the CCA, with or without concomitant CEA, between 2016 and 2023 was performed. Overall, 33 patients were treated. A total of 15 patients (45.5%) were male, with the mean age being 67 ± 9.1 years, and 58% (n = 19) of the patients presented with neurological symptoms. Open retrograde stenting was performed in 67% (n = 22) in ACC, and in 33% (n = 11) in IA stenosis. A total of 20 patients (61%) underwent retrograde stenting with synchronous ipsilateral CEA for concomitant stenosis of the carotid bifurcation. There was no 30-day mortality. The perioperative stroke rate was 3% (n = 1) with complete symptom recovery. During the follow up at 32 months (95% CI: 24-39), three late deaths (9.1%) and one symptomatic stent occlusion were observed and, in five patients (15.2%), re-intervention for restenosis was necessary. Open retrograde stenting for of proximal IA or CCA stenosis with or without CEA, in case of tandem carotid lesions, can be performed safely with a low rate of early adverse events. Continuous follow up examinations are necessary due to relevant instent re-stenosis rates.

Endoscopic gallbladder inside-stenting combined with aspirated lavage for calculous cholecystitis in poor surgical candidates: a prospective pilot study

Although long-term stent placement via endoscopic gallbladder stenting (EGBS) reportedly reduces cholecystitis recurrence in patients unfit to undergo cholecystectomy, it can increase the frequency of other late adverse events (AEs) such as cholangitis. This study aimed to examine the feasibility of endoscopic gallbladder inside-stenting (EGB-IS) with lavage and aspiration. This prospective, single-center, pilot study enrolled 83 patients with acute calculous cholecystitis who were poor candidates for surgery. A dedicated catheter with eight side holes was used for lavage and aspiration, and a dedicated single-pigtail stent equipped with a thread was used for EGB-IS. Outcomes such as technical success, clinical success, early AEs, recurrence of cholecystitis, and other symptomatic late AEs associated with EGB-IS with lavage and aspiration were evaluated. The technical and clinical success rates were 80.7% (67/83) and 98.5% (66/67), respectively. The rate of early AEs was 3.6% (3/83). The rate of recurrent cholecystitis was 4.5% (3/66) and that of symptomatic late AEs (besides cholecystitis) was 6.1% (4/66). Consequently, the rate of overall late AEs (cholecystitis plus other events) was 10.6% (7/66). The 1-, 2-, and 3-year cumulative incidence rates of all late AEs were 3.2%, 11.2%, and 18.9%, respectively. EGB-IS with lavage and aspiration for calculous cholecystitis showed promising results in poor surgical candidates. EGB-IS may be useful when EGBS with long-term stent placement is planned, since prevention of cholecystitis recurrence, without a rise in the incidence of other AEs, is anticipated.

Racial disparities in early adverse events and unplanned readmission after open fixation of fractures distal to the knee

Abstract Objectives: To determine whether (1) early postoperative complications and (2) time to surgery for operative fixation of fractures distal to the knee differ for Black versus White patients and to assess whether disparities exist within fracture subtypes. Design: Retrospective database review. Setting: Hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program database. Patients/Participants: Patients (18 years or older) undergoing open fixation of fractures distal to the knee between 2010 and 2019 (n = 9172 patients). Intervention: Open reduction and internal fixation of fractures distal to the knee. Main Outcome Measurements: Thirty-day postoperative complications and time to surgery by race, as compared by multivariable regression with nearest-neighbor propensity score matching. Results: Of the 9172 patients in our cohort, 1120 (12%) were Black. After matching, we identified 1120 White patients with equal propensity scores as our Black patients. Black patients had 1.5 times higher odds (95% confidence interval [CI]: 1.0–2.0) of experiencing any early adverse event when compared with matched White counterparts. Black patients also had 1.9 times higher odds (95% CI: 1.2–3.0) of requiring unplanned readmission within 30 days of operative fixation. There were no significant differences by race in time to surgery. Fracture subtype (tibia/fibula shaft, isolated malleolar, bi/trimalleolar, and pilon fractures) was not associated with postoperative complications or time to surgery in the multivariable analysis. Conclusion: Racial disparities in the early postoperative course after open fixation of fractures distal to the knee exist, with significantly higher rates of early adverse events and unplanned readmission persist for Black versus White patients after propensity matching. Level of Evidence: Prognostic level III.

Racial Disparities in Early Adverse Events and Unplanned Readmission after Open Fixation of Below- Knee Fractures

Category: Trauma; Ankle; Hindfoot; Other Introduction/Purpose: Race-based differences in the surgical management of hip fractures are well-established. Studies assessing these disparities for below-knee fractures have yet to be conducted despite their high volume. Our purpose was to determine whether 1) early postoperative complications and 2) time to surgery for operative fixation of below-knee fractures differ for black versus white patients, and to assess whether disparities exist between fracture subtypes. Methods: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database was queried for patients (>=18 years) undergoing open fixation of below-knee fractures between 2010-2019. This yielded 9,172 patients; 1,120 (12%) were black. We collected patient demographics and preoperative risk factors. Primary outcomes were 30-day postoperative complications and time to surgical fixation. Fractures were further subclassified as tibia and/or fibula shaft, isolated malleolar, bi/trimalleolar, and pilon fractures. Nearest-neighbor propensity score matching in a 1:1 ratio was applied to compare outcomes by race. Alpha = 0.05. Results: After matching, we identified 1,120 white patients with equal propensity scores as our black patients. Black patients had 1.5 times higher odds (95% confidence interval [CI]: 1.0-2.0) of experiencing any early adverse event when compared with matched white counterparts. Blacks also had 1.9 times higher odds (95% CI: 1.2-3.0) of requiring unplanned readmission within 30 days of operative fixation. Fifty-eight black patients (5.3%) required short-term readmission, compared with 351 white patients (4.5%) - 32 (2.9%) in the matched cohort. The most common reasons for readmission were wound, gastrointestinal, thromboembolic, and recurrent musculoskeletal complications for both races. There were no significant differences by race in time to surgery. Fracture subtype was not associated with postoperative complications or time to surgery in the multivariable analysis. Conclusion: Racial disparities in the early postoperative course after open fixation of below-knee fractures exist, with significantly higher rates of early adverse events and unplanned readmission for black versus white patients that persist after propensity matching. These trends may be secondary to a host of community- and hospital-level factors, illustrating the importance of interventions that consider the differences between hip and non-hip fractures and increase resources to vulnerable areas.

Comparison of Early and Late Postoperative Outcomes Between INTERMACS 1/2 vs. 3/4

<h3>Purpose</h3> The INTERMACS profiles are established as important selection and prognostic criteria for Left Ventricular Assist Devices (LVAD) implantation. We sought to investigate the correlation of higher acuity INTERMACS profile and post-LVAD implantation outcomes in carefully selected and optimized patients. <h3>Methods</h3> We conducted a retrospective analysis of all HeartMate 3 LVAD (HM3) implantations in our institution between September 2015 and April 2021. Baseline characteristics and clinical outcomes were compared based on pre-implantation INTERMACS profiles: 1 and 2 (IP1-2) vs. 3 and 4 (IP3-4). Our primary study endpoint was the composite of stroke events and death from time of HM3 implantation through late follow-up. <h3>Results</h3> Of 234 patients implanted with a HM3 during the study period, 116 (49.6%) presented in cardiogenic shock IP1-2, while 118 (50.4%) were less acute IP3-4 (Table 1). Patients in IP1-2 at time of LVAD implantation were younger with de-novo heart failure and worse end-organ function. Postoperatively, patients in the IP1-2 group experienced higher rates of early adverse events including severe right ventricular failure (9% vs. 3%, p=0.025) and prolonged hospital length of stay. There was no statistically significant difference in the Kaplan-Meier estimator (Figure 1.) for the composite end-point of death and stroke between IP groups. <h3>Conclusion</h3> INTERMACS 1/2 patients implanted with HM3 LVAD were younger, had longer intubation times, and longer ICU and hospital lengths of stay. Clinical outcomes were similar between the groups with INTERMACS 3/4 patients showing a trend toward a lower composite event rate of stroke and death.

Characteristics and Outcomes of Patients with Inflammatory Cardiomyopathies Receiving Mechanical Circulatory Support: An STS–INTERMACS Registry Analysis

BackgroundDurable mechanical circulatory support (MCS) therapy improves survival in patients with advanced heart failure. Knowledge regarding the outcomes experienced by patients with inflammatory cardiomyopathy (CM) who receive durable MCS therapy is limited. Methods and ResultsWe compared patients with inflammatory CM with patients with idiopathic dilated CM enrolled in the STS–INTERMACS registry. Among 19,012 patients, 329 (1.7%) had inflammatory CM and 5978 had idiopathic dilated CM (31.4%). The patients with inflammatory CM were younger, more likely to be White, and women. These patients experienced more preoperative arrhythmias and higher use of temporary MCS. Patients with inflammatory CM had a higher rate of early adverse events (<3 months after device implant), including bleeding, arrhythmias, non–device-related infections, neurologic dysfunction, and respiratory failure. The rate of late adverse events (≥3 months) was similar in the 2 groups. Patients with inflammatory CM had a similar 1-year (80% vs 84%) and 2-year (72% vs 76%, P = .15) survival. Myocardial recovery resulting in device explant was more common among patients with inflammatory CM (5.5% vs 2.3%, P < .001). ConclusionsPatients with inflammatory CM who received durable MCS appear to have a similar survival compared with patients with idiopathic dilated CM despite a higher early adverse event burden. Our findings support the use of durable MCS in an inflammatory CM population.

Does the 45 mm Size Cutoff for Ascending Aortic Replacement Predict Better Early Outcomes in Bicuspid Aortic Valve?

The aim of this study is to test if the newly proposed 45 mm size criterion for ascending aortic replacement (AAR) in bicuspid aortic valve (BAV) patients undergoing aortic valve replacement (AVR) is predictive of improved early outcomes. Data of 306 BAV patients with an aortic diameter of ≥45 mm undergoing AVR alone or with AAR were retrospectively analyzed. Patients were divided into groups of AVR + AAR (n = 220) and AVR only (n = 86) based on if surgery was performed according to the 45 mm criterion. End point was early adverse events, including 30-day and in-hospital mortality, cardiac events, acute renal failure, stroke, and reoperation for bleeding. Cox regression was used to assess if conformance to 45 mm criterion could predict fewer early adverse events. AVR + AAR group had significantly higher postoperative left ventricular ejection fraction (LVEF) (0.59 ± 0.09 vs. 0.55 ± 0.11, p = 0.006) and longer cardiopulmonary bypass (CPB) time (128 vs. 111 minutes, p = 0.002). Early adverse events occurred in 45 patients (14.7%), which was more prevalent in the AVR-only group (22.1% vs. 11.8%, p = 0.020). Conformance to the 45 mm criterion predicted lower rate of early adverse events (hazard ratio [HR]: 0.53, 95% confidence interval [CI]: 0.28-0.98, p = 0.042). After adjustment for gender, age, AAo diameter, sinuses of Valsalva diameter, preoperative LVEF, Sievers subtypes, BAV valvulopathy, and CPB and cross-clamp times, conformance to the 45 mm size criterion still predicted lower incidence of early adverse events (HR: 0.37, 95% CI: 0.15-0.90, p = 0.028). This study shows that conformance to 45 mm size cutoff for preemptive AAR during aortic valve replacement in patients with BAV was not associated with increased risk for adverse events and may improve early surgical outcomes.

Endoscopic Ultrasonography-Guided Gastroenterostomy Techniques for Treatment of Malignant Gastric Outlet Obstruction

Gastric outlet obstruction (GOO) can be caused by periampullary malignancies and often leads to a reduction in a patient’s quality of life. Recently, endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) using a lumen-apposing self-expandable metal stent (LAMS) has been developed as a minimally invasive and durable endoscopic treatment for GOO. There are three types of EUS-GE technique: (1) the direct technique; (2) device-assisted techniques, such as a balloon catheter, nasobiliary drainage tube, and ultraslim endoscopy; and (3) EUS-guided double balloon-occluded gastrojejunostomy bypass. Previous reports of EUS-GE with LAMS have shown technical and clinical success rates (regardless of technique and etiology) of 87%–100% and 84%–100%, respectively. Studies comparing EUS-GE and surgical gastrojejunostomy have shown similar success rates, reintervention rates, and cost benefits, with a lower rate of early adverse events in EUS-GE. A comparison of EUS-GE and endoscopic enteral stent placement revealed similar technical success rates, but initial clinical success rate was higher and the rate of stent failure requiring reintervention was lower with EUS-GE.

Feasibility of balloon endoscope-assisted endoscopic retrograde cholangiopancreatography for the elderly.

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) for patients with surgically altered anatomy is challenging. Recently, balloon endoscopy has been shown to facilitate ERCP for this population with a high technical success rate, but adverse events (AEs) are not uncommon. Compared to non-elderly patients, elderly patients may be at higher risk of AEs due to underlying comorbidities. The current study aimed to evaluate the feasibility of balloon endoscope-assisted ERCP (BE-ERCP) for the elderly. Patients and methods We retrospectively identified patients who underwent BE-ERCP between January 2010 and September 2019. For patients who underwent multiple procedures during the study period, the first session was analyzed. Early AEs associated with BE-ERCP were compared between elderly (≥ 75 years) and non-elderly patients. Results A total of 1,363 BE-ERCP procedures were performed, and 568 patients (211 elderly and 357 non-elderly) were included for the analyses. Technical success rates were high in both the elderly and non-elderly groups (80 % vs. 80 %, respectively). The rates of early AEs were similar between the groups (12 % vs. 9.0 % in the elderly and non-elderly group, respectively; P = 0.31). The mltivariable-adjusted odds ratio for early AEs comparing elderly to non-elderly patients was 1.36 (95 % confidence interval, 0.74–2.51; P = 0.32). Specifically, we did not observe between-group differences in rates of gastrointestinal perforation (2.4 % vs. 2.8 % in elderly and non-elderly groups, respectively; P = 0.99) and aspiration pneumonia (1.9 % vs. 0.6 %, P = 0.20). Conclusions BE-ERCP is a feasible procedure for elderly individuals with surgically altered anatomy.

Is Immediate Weight-Bearing Safe After Single Implant Fixation of Elderly Distal Femur Fractures?

To compare early complications in elderly patients with extra-articular distal femur fractures (DFFs) allowed to weight-bear as tolerated (WBAT) immediately versus patients prescribed initial touchdown weight-bearing (TDWB). Retrospective cohort study. Level 1 academic trauma center. One hundred thirty-five patients 60 years or older who underwent surgical fixation of an extra-articular DFF, including the OTA/AO fracture classification of 33-A1-3, and periprosthetic fractures with a stable knee prosthesis (Lewis and Rorabeck type I or II) with at least 6 months follow-up. Immediate WBAT or TDWB after surgical fixation of an extra-articular DFF with either an intramedullary nail or locked plate. The primary outcome was a major adverse event within the first 6 months, defined as (1) early fixation failure or change in alignment leading to reoperation, (2) nonunion, or (3) deep infection. Secondary outcomes included postoperative inpatient length of stay, discharge disposition (secondary facility vs. home), malunion, mortality, and patient-reported outcomes. The rate of early adverse events requiring reoperation was similar between the WBAT group (6, 10.7%) and the TDWB group (15, 19.0%; P = 0.23). There was no difference between groups with respect to length of stay, discharge disposition, malunion, and patient-reported outcomes. This study supports allowing carefully selected elderly patients, based on surgeon preference, to immediately weight-bear after operative fixation of an extra-articular DFF regardless of implant choice. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Mo1285 SAFETY AND EFFICACY OF MULTIBAND MUCOSECTOMY AND ENDOSCOPIC CAP RESECTION IN EARLY BARRETT’S NEOPLASIA: A SYSTEMATIC REVIEW AND META-ANALYSIS

Endoscopic cap resection (CAP-R) and Multiband mucosectomy (MBM) are the two most commonly used endoscopic mucosal resection (EMR) procedures for early Barrett’s neoplasia. MBM is a newer method of EMR that does not require submucosal lifting and is technically easier to perform that CAP-R. We performed a systematic review and meta-analysis to compare the overall safety and efficacy of both these procedures for early Barrett’s neoplasia. We conducted a comprehensive search of multiple electronic databases and conference proceedings including PubMed, EMBASE, Web of Science databases, Google Scholar and manual search of references (from inception through Oct 2019) to identify the studies reporting use of MBM and CAP-R for early Barrett’s neoplasia. The primary outcome was to evaluate the technical success of the procedures which was defined as complete endoscopic resection of a delineated focal lesion. The secondary outcome was to study overall, early and delayed adverse events related to the procedures. The meta-analysis was performed using Der Simonian and Laird random effect model. 15 studies (N=1176 and no. of lesions=1487) reporting on MBM and 15 studies (N=653 and no. of lesions=785) reporting on CAP-R were included in our final analysis. The mean age was 64 years and 61.8 years in MBM group and CAP-R group respectively. The pooled technical success rates were 99.1% (95% CI 96.76-100, I2=81.51) in MBM group versus 94.2% (95% CI 84.61-99.69, I2=93.45) in CAP -R group with p-value of 0.139. (Table 1) The total early adverse event rates were 9.41% (95% CI 1.97-20.39, I2= 292.37) in CAP-R group versus 5.87% (95% CI 2.61-10.02, I2=78.26) in MBM group with p-value of 0.458. (Table 2) The most common early adverse events were bleeding with 5.09% (95% CI 1.97-9.19, I2=79.59) in MBM group and 5.95% (95% CI 2.47-10.46, I2=92.7) in CAP-R group. The most common delayed adverse events were stricture formation with 10.99% (95% CI 5.67-17.53, I2=86.84) in MBM group and 3.03% (95% CI 0.39-7.2, I2=74.88) in CAP-R group. The mean procedure time for MBM was shorter (23.3 min; reported in six studies) as compared to CAP-R (29.31 min; reported in six studies). Significant heterogeneity was noted in in our meta-analysis. Although in our study, MBM had similar pooled technical success rate as CAP-R in early Barrett’s neoplasia (p-value =0.139) but procedure times were shorter as compared to CAP-R. Further large multicenter randomized controlled trials are needed for further validation of our findings.Table 2Forest Plot showing overall early adverse events of MBM and CAP-RView Large Image Figure ViewerDownload Hi-res image Download (PPT)

Multicenter randomized trial of endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy for removal of bile duct stones: MARVELOUS trial.

BACKGROUND : Endoscopic papillary large balloon dilation (EPLBD) has been increasingly used for the management of large common bile duct (CBD) stones. Although EPLBD is often preceded by endoscopic sphincterotomy (EST), EPLBD alone without EST has been increasingly reported as an alternative to EST for large CBD stones. METHODS : This multicenter randomized trial was conducted at 19 Japanese institutions to compare the efficacy and safety of EPLBD alone versus EST for the removal of large (≥ 10 mm) CBD stones. The primary end point was complete stone removal in a single session. The secondary end points included: overall complete stone removal, lithotripsy use, procedure time, adverse events, and cost. RESULTS: 171 patients with large CBD stones were included in the analysis. The rate of single-session complete stone removal was significantly higher in the EPLBD-alone group than in the EST group (90.7 % vs. 78.8 %; P = 0.04). Lithotripsy use was significantly less frequent in the EPLBD group than in the EST group (30.2 % vs. 48.2 %; P = 0.02). The rates of early adverse events were comparable between the two groups: rates of overall adverse events were 9.3 % vs. 9.4 % and of pancreatitis were 4.7 % vs. 5.9 % in the EPLBD and EST groups, respectively. The procedure costs were $1442 vs. $1661 in the EPLBD and EST groups, respectively (P = 0.12). CONCLUSION : EPLBD without EST for the endoscopic treatment of large CBD stones achieved a significantly higher rate of complete stone removal in a single session compared with EST, without increasing adverse events.

399 Safety and Efficacy of Multiband Mucosectomy in Early Barrett's Neoplasia: A Systematic Review and Meta-Analysis

INTRODUCTION: Endoscopic mucosal resection (EMR) is treatment of choice for early Barrett’s neoplasia. Multiband mucosectomy (MBM) is a type of EMR procedure used for diagnosis and treatment of early Barrett’s neoplasia. This procedure has an advantage over cap-resection as it does not require submucosal lifting. We performed systematic review and meta-analysis to compare the overall safety and efficacy of this procedure for early Barrett’s neoplasia. METHODS: We conducted a comprehensive search of multiple electronic databases and conference proceedings including PubMed, EMBASE, Web of Science databases, Google Scholar and manual search of references (from inception through May 2019) to identify the studies reporting use of MBM for early Barrett’s neoplasia. The primary outcome was to evaluate the technical success of the procedure which was defined as complete endoscopic resection of a delineated focal lesion. The secondary outcome was to study overall, early and delayed adverse events related to the procedure. The meta-analysis was performed using Der Simonian and Laird random effect model. RESULTS: 15 studies reporting on 1197 patients with 1487 lesions were included. Majority of the patient population were males (80.8%), with mean age of 64 years. The pooled technical success rates were 99.1% (95% CI 96.76-100, I2 = 81.51) and the total early adverse event rates were 5.87% (95% CI 2.61-10.02, I2 = 78.26). The most common early and delayed adverse events were bleeding (5.09%; 95% CI 1.97-9.19, I2 = 79.59) and strictures (10.99%; 95% CI 5.67-17.53, I2 = 86.84) respectively. Total 5 perforations were reported in our patient population. The mean procedure time was 23.3 min reported in six studies. Significant heterogeneity was noted in in our meta-analysis. CONCLUSION: Multiband mucosectomy is a safe alternative procedure to endoscopic cap resection for the treatment of early Barrett’s neoplasia with high technical success and lower adverse events. Further large multicenter randomized controlled trials are needed for further validation of our findings.

Abstract 231: Outcome Variations Between Patients Prescribed Direct Oral Anticoagulant or Warfarin

Background: Patients with cardiovascular disease (CVD) require antithromobotic therapy to reduce risk of embolization. Direct oral anticoagulants (DOAC) were introduced to widespread clinic use in 2010. This study explores differences in demographics and outcomes (readmission, ED visit, death) between patients on a DOAC or warfarin, and the impact of attending a cardiac transitional care appointment (BRIDGE) on outcomes between groups. Methods: Data from patients in the BRIDGE dataset from 2010-2017 were analyzed, excluding those with an adverse event prior to their BRIDGE appointment. Demographics and outcomes of patients prescribed warfarin were compared with those prescribed a DOAC. Outcomes for each group were further compared by BRIDGE clinic attendance. Results: Prescribing of DOACs has linearly increased from 2010-2017. Of 666 anticoagulated patients, 22.5% (n=150) were prescribed a DOAC and 77.5% (n=516) were prescribed warfarin, for any indication. Warfarin patients had higher CHA2DS2-VASc scores and were more likely to visit the ED within 30 days than DOAC patients. DOAC patients were more likely to be readmitted within 6 months. Both warfarin and DOAC patients who attended BRIDGE were less likely to have a readmission within 6 months than patients who did not attend. DOAC patients who attended BRIDGE were also less likely to have an ED visit within 6 months than DOAC patients who did not attend. However, patients with a 30 day adverse event were more likely to have attended BRIDGE (readmission: DOAC 90%, 9/10; warfarin 73.8%, 31/42; ED: DOAC 100%, 5/5; warfarin 78.7, 37/47). Conclusion: Since introduction, DOAC prescription has continuously increased. Warfarin patients had higher CHA2DS2-VASc scores and higher rates of early adverse events (ED visit) than DOAC patients. DOAC patients had higher rates of late adverse events (readmission in 6 months). The differences in early and late readmissions may be partially explained by the necessity of early follow up for those prescribed warfarin at discharge. However, early readmissions overall were more likely to have attended BRIDGE. This suggests that early follow up frequently identifies anticoagulated patients in need of hospitalization, and the importance of prompt transitional care among this population.

Endoscopic papillary large balloon dilation without sphincterotomy for users of antithrombotic agents: A multicenter retrospective study.

With an aging population, an increasing number of individuals on antithrombotic agents are diagnosed with large bile duct stones. Studies have shown the effectiveness of endoscopic papillary large balloon dilation (EPLBD) for removal of large bile duct stones. EPLBD without endoscopic sphincterotomy (EST) may reduce the risk of procedure-related bleeding, but the safety of this procedure for users of antithrombotic agents remains unclear. In this multicenter retrospective study, we included patients who underwent EPLBD without EST for bile duct stones between March 2008 and December 2017. We compared adverse events and other clinical outcomes between users and non-users of antithrombotic agents (antiplatelet agents and anticoagulants). We analyzed a total of 144 patients (47 users and 97 non-users of antithrombotic agents). Among the users, the agents were continued in 13% and were replaced with heparin in 62% during the periprocedural period. We did not observe clinically significant bleeding and thrombotic events irrespective of the use of antithrombotic agents. Overall rate of early adverse events did not differ between users and non-users (6.4% and 7.2%, P = 0.99). Procedural outcomes did not differ between the groups (necessity for lithotripsy, 28% vs. 29%; and complete stone removal in a single session, 72% vs. 71%, for users and non-users, respectively). Endoscopic papillary large balloon dilation without EST may be done without a substantial increase in procedure-related bleeding for users of antithrombotic agents. A larger study is required to refine the management strategy for those agents during the periprocedural period.

Shoulder Arthroplasty in Patients with Rheumatoid Arthritis: A Population-Based Study Examining Utilization, Adverse Events, Length of Stay, and Cost.

It has been suggested that the utilization of joint arthroplasty in patients with rheumatoid arthritis (RA) is decreasing; however, this observation is largely based upon evidence pertaining to lower-extremity joint arthroplasty. It remains unknown if these observed trends also hold true for shoulder arthroplasty. The purpose of this study is to utilize a nationally representative population database in the US to identify trends in the utilization of shoulder arthroplasty among patients with RA. Secondarily, we sought to determine the rate of early adverse events, length of stay, and hospitalization costs associated with RA patients undergoing shoulder arthroplasty and to compare these outcomes to those of patients without a diagnosis of RA undergoing shoulder arthroplasty. Using a large population database in the US, we determined the annual rates of shoulder arthroplasty (overall and individual) in RA patients between 2002 and 2011. Early adverse events, length of stay, and hospitalization costs were determined and compared with those of non-RA patients undergoing shoulder arthroplasty. Overall, we identified 332,593 patients who underwent shoulder arthroplasty between 2002 and 2011, of whom 17,883 patients (5.4%) had a diagnosis of RA. Over the study period, there was a significant increase in the utilization of shoulder arthroplasty in RA patients, particularly total shoulder arthroplasty. Over the same period, there was a significant increase in the number of RA patients who underwent shoulder arthroplasty with a diagnosis of rotator cuff disease. There were no significant differences in adverse events or mean hospitalization costs between RA and non-RA patients. Non-RA patients had a significantly shorter length of stay; however, the difference did not appear to be clinically significant. In conclusion, the utilization of shoulder arthroplasty in patients with RA significantly increased from 2002 to 2011, which may partly reflect a trend toward management of rotator cuff disease with arthroplasty rather than repair.

The intra-conduit release method is useful for avoiding migration of metallic stents during EUS-guided hepaticogastrostomy (with video).

Although EUS-guided hepaticogastrostomy (EUS-HGS) with a covered self-expandable metal stent (SEMS) is a useful procedure, it is associated with severe adverse events, including stent migration. We, therefore, developed an intra-conduit release method, and investigated whether the technique yields a safer and more stable procedure. The intra-conduit release method is a procedure to release the SEMS in the working channel conduit of the scope for anchoring between the liver and stomach to avoid stent migration. Forty-three patients who underwent EUS-HGS at two high-volume centers in Japan were enrolled in this retrospective study, and the safety and usefulness of this method were evaluated retrospectively. The intra-conduit release method was applied in 36 cases. The technical success rate of EUS-HGS with the intra-conduit release method was significantly higher in comparison with the conventional method. Additionally, the rate of early adverse events was significantly lower than that for the conventional method. The intra-conduit release method during EUS-HGS is useful for a stable procedure that avoids early adverse events.

Early adverse events and long-term outcomes of endoscopic sphincterotomy in a pediatric population: a single-center experience.

Background and aims: The use of endoscopic sphincterotomy (EST) in the management of pancreaticobiliary disease in children is increasing. However, studies of long-term outcomes are limited in pediatric patients. Therefore, this study evaluated the early adverse events and long-term outcomes following EST in pediatric patients. Patients and methods: We retrospectively analyzed data from 198 pediatric patients who underwent ESTs at Asan Medical Center Children's Hospital between 1994 and 2013. The median age was 8.7 years (range 18 months to17 years). We evaluated the indications, success rates, early adverse events, and long-term outcomes. Results: Long-term information was available in 198 patients with a median follow-up duration of 42 months (range, 1.8 - 232.1 months). Early adverse events (< 30 days) following 294 ESTs among 198 patients included pancreatitis in 17 (5.7 %), hemorrhages in 6 (2.0 %), sepsis in 3 (1.0 %), and perforations in 2 (0.7 %). Long-term complications ( > 30 days) developed in 12 patients (6.1 %), including cholangitis with or without bile duct stone (n = 7), and minor papilla restenosis (n = 5). The cumulative incidence rates of long-term complications were 3.1 %, 6.1 %, 9.3 %, and 9.3 %, at 1, 5, 10, and 15 years. There were no procedure-related pancreaticobiliary malignancies or deaths. All adverse events and long-term complications improved with appropriate management. Conclusions: In pediatric patients with pancreaticobiliary disease, EST has a high level of technical success. In addition, pediatric EST showed low rates of early adverse events and long-term complications, which could be managed safely. Our results suggest that EST is a safe method for treating pancreaticobiliary disease, even in the pediatric population.

Adverse events in children implanted with ventricular assist devices in the United States: Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS)

Ventricular assist devices (VADs) have been used in children on an increasing basis in recent years. One-year survival rates are now >80% in multiple reports. In this report we describe adverse events experienced by children with durable ventricular assist devices, using a national-level registry (PediMACS, a component of INTERMACS) METHODS: PediMACS is a national registry that contains clinical data on patients who are <19 years of age at the time of VAD implantation. Data collection concludes at the time of VAD explantation. All FDA-approved devices are included. PediMACS was launched on September 1, 2012, and this report includes all data from launch until August 2014. Adverse events were coded with a uniform, pre-specified set of definitions. This report comprises data from 200 patients with a median age of 11 years (range 11 days to 18 years), and total follow-up of 783 patient-months. The diagnoses were cardiomyopathy (n = 146, 73%), myocarditis (n = 17, 9%), congenital heart disease (n = 35, 18%) and other (n = 2, 1%). Pulsatile-flow devices were used in 91 patients (45%) and continuous-flow devices in 109 patients (55%). Actuarial survival was 81% at 6 months. There were 418 adverse events reported. The most frequent events were device malfunction (n = 79), infection (n = 78), neurologic dysfunction (n = 52) and bleeding (n = 68). Together, these accounted for 277 events, 66% of the total. Although 38% of patients had no reported adverse event and 16% of patients had ≥5 adverse events. Adverse events occurred at all time-points after implantation, but were most likely to occur in the first 30 days. For continuous-flow devices, there were broad similarities in adverse event rates between this cohort and historic rates from the INTERMACS population. In this study cohort, the overall rate of early adverse events (within 90 days of implantation) was 86.3 events per 100 patient-months, and of late adverse events it was 20.4 events per 100 patient-months. The most common adverse events in recipients of pulsatile VADs were device malfunction, neurologic dysfunction, bleeding and infection. For continuous-flow VADs, the most common adverse events were infection, bleeding, cardiac arrhythmia, neurologic dysfunction and respiratory failure. Compared with an adult INTERMACS cohort, the overall rate and distribution of adverse events appears similar.

Early outcomes after isolated aortic valve replacement with rapid deployment aortic valve

ObjectiveMinimal access aortic valve replacement is associated with favorable clinical outcomes; however, several meta-analyses have reported significantly longer crossclamp times compared with a full sternotomy. We examined the procedural and early safety outcomes after isolated rapid deployment aortic valve replacement by surgical approach in patients enrolled in the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve trial. MethodsThe Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve trial was a prospective, multicenter, single-arm study, with successful implants in 287 patients with aortic valve stenosis who underwent rapid deployment aortic valve replacement using the EDWARDS INTUITY Valve System (Edwards Lifesciences, Irvine, Calif). Patients were evaluated perioperatively for procedural times and technical success rates; at discharge, for hospital length of stay; and, at 30 days, for early adverse events. ResultsA total of 158 patients underwent isolated aortic valve replacement through a full sternotomy (n = 71), upper hemisternotomy (n = 77), or right anterior thoracotomy (n = 10). Mean age at baseline was 75.7 ± 7.2 years. Mean aortic crossclamp and cardiopulmonary bypass times (minutes) were similar for full sternotomy and upper hemisternotomy, 43.5 ± 32.5/71.6 ± 41.8 and 43.1 ± 13.1/69.6 ± 19.1, respectively, and significantly longer for right anterior thoracotomy, 88.3 ± 18.6/122.2 ± 22.1 (P < .000). Early adverse event rates were similar, and in-hospital mortality rates were low regardless of surgical approach. ConclusionsThese data suggest that isolated rapid deployment aortic valve replacement through an upper hemisternotomy can lead to shorter crossclamp times than has been reported historically in the literature. This may facilitate minimal access aortic valve replacement by eliminating the issue of prolonged crossclamp times. Further, low in-hospital mortality and new permanent pacemaker implant rates were observed regardless of surgical approach.