Postprocedural Bleeding Research Articles

Clinical Outcomes in Atrial Fibrillation Patients Undergoing Transcatheter Aortic Valve Replacement With Contemporary Devices.

Atrial fibrillation (AF) has been identified as a marker of advanced cardiac damage in aortic stenosis patients. However, the factors associated with poorer outcomes among AF patients in contemporary TAVR practice, particularly regarding mortality and heart failure (HF)-related hospitalizations, remain largely unknown. Multicenter study including consecutive patients with a history of AF, evaluating the clinical outcomes and predictors of mortality, and HF-related hospitalization, who underwent TAVR with newer-generation devices using balloon or self-expandable valves. A total of 3,476 patients were included. After a median follow-up of 2 (1-4) years, 36.4% had died, with 51.5% of deaths being cardiovascular-related, including 15.6% from HF. HF-related hospitalizations post-TAVR accounted for 34.8% of all hospitalizations and exhibited a significantly higher mortality risk (HR:1.54;95%CI:1.32-1.81;P<0.001). Permanent AF emerged as an independent predictor of all-cause death or HF-related hospitalizations (HR:1.25; 95%CI:1.10-1.40;P<0.001), as did other baseline characteristics, including chronic kidney disease (HR:1.23;95%CI:1.09-1.38;P=0.001), anemia (HR:1.21; 95%CI:1.07-1.36;P=0.002), and New York Heart Association class III or IV (HR:1.13; 95%CI:1.01-1.27;P=0.045). Additionally, early post-procedural complications, including stroke and bleeding also significantly increased the risk of mortality and HF-related hospitalizations (HR:5.52;95%CI:3.12-9.79;P<0.001 & HR:1.17;95%CI:1.03-1.33;P=0.014, respectively). AF patients exhibited a high risk of HF-related hospitalizations in a contemporary TAVR cohort. Several baseline co-morbidities and periprocedural complications, along with permanent (vs. paroxysmal) AF were associated with poorer outcomes. These findings confirm the negative impact of AF despite the continued improvements in TAVR technology and underscore the importance of early intervention and optimization of HF management to improve outcomes in this high-risk population.

Endoscopic Local Excision (ELE) with Knife-Assisted Resection (KAR) Techniques Followed by Adjuvant Radiotherapy and/or Chemotherapy for Invasive (T1bsm2,3/T2) Early Rectal Cancer: A Multicenter Retrospective Cohort.

Background: Resected rectal polyps with deep invasion into the submucosa (pT1b-sm2,3) or the muscle layer (pT2) are currently confronted with surgery due to non-curative resection. Aims: We evaluated the efficacy, safety, and locoregional control of adjuvant radiotherapy (RT) and/or chemotherapy (CT) following endoscopic KAR (knife-assisted resection) in patients with invasive early rectal cancers who are unwilling or unsuitable for additional surgical resection. Methods: Fifty-one patients with early rectal cancers, pT1b or pT2, underwent post-resection adjuvant RT and/or CT in 15 centers worldwide. "En bloc" macroscopic resection, R0 resection, recurrence rate, and adverse events following resection and adjuvant therapy were recorded in a multicenter retrospective cohort study. Results: Diagnostic staging (38/51, 75%) was the main reason for ELE. Macroscopic "en bloc" resection was demonstrated in 50/51 (98%), with an average follow-up of 20.6 months. Endoscopic recurrence occurred in 7/51 (13.7%) of patients, with mean time for diagnosis of recurrence at 8.9 months. Adjuvant therapy consisted of RT in 49.0% (25/51), CT in 11.8% (6/51), and combined CRT in 39.2% (20/51) of the cases. Perforation, severe post-procedural bleeding, and incontinence were the most frequent complications. The absence of superficial ulceration was associated with macroscopic complete resection, while the lesions with lower budding stage, clear lateral margins, lesion size < 40 mm, and needle-type knife used were associated with less endoscopic recurrencies. Conclusions: Our data investigated adjuvant RT and/or CT after endoscopic KAR of infiltrative rectal cancers (pT1bsm2,3-pT2) as being safe and effective for locoregional control and providing a non-surgical treatment option for patients with a non-curative resection.

Endoscopic polidocanol foam sclerobanding for treatment of internal hemorrhoids: A novel outpatient procedure.

In the study, we comment on the article by Qu et al. Internal hemorrhoids are the most common anorectal disorders worldwide with bleeding, prolapse, and difficulty in defecation. Endoscopic rubber band ligation (ERBL) is a safe, convenient, quick, and economical outpatient procedure. The main goal of ERBL is to alleviate prolapse, but the high incidence of recurrence and post-procedural pain are of clinical concern. Polidocanol foam as a local hemostatic and anesthetic agent could reduce the rates of post-procedural pain and bleeding. Endoscopic polidocanol foam sclerobanding (EFSB) is a novel approach that could lift the mucosa for easy ligation and promote increased scarring in the submucosal tissue which translates into long-term relief from prolapse recurrence and reduced 24-h post-procedural pain. The study by Qu et al is a novel multi-center prospective randomized study to compare ERBL and EFSB in patients with grades II and III internal hemorrhoids with one-year follow-up. Results showed that EFSB is a novel therapy for internal hemorrhoids, but future studies with a larger sample, multiple treatment sessions, and long-term follow-up are required to confirm these findings.

HPB SO21 - Percutaneous Biliary Endoscopy for Managing Disease in Endoscopically Inaccessible Biliary Trees: A Single Unit Experience in the UK

Abstract Background Patients with a history of hepatobiliary surgery often require interventions for complications such as hepatolithiasis, recurrent disease, or anastomotic strictures. Access to the biliary tree in these, and other post-operative patients, is hindered by a diverted alimentary tract or comorbidities that preclude endoscopy or re-operation. While forms of biliary endoscopy have been used for many years in combination with ERCP, recent advances now allow for the combination of percutaneous radiological interventions with cholangioscopy. We share our early experiences and outcomes using percutaneous biliary endoscopy (PBE) to manage a challenging cohort of patients Method In our hospital trust, a multidisciplinary team consisting of Interventional Radiologists, endoscopy staff, and a Hepatobiliary Surgeon performed some of the first PBE procedures using the SpyGlass device in the UK. The biliary tree was accessed under ultrasound and fluoroscopic guidance, followed by tract dilation to admit a 12F sheath. This allowed use of the SpyGlass device, along with adjuncts such as electrohydraulic lithotripsy catheters, dilation balloon catheters, biopsy forceps, and biodegradable stents through the working channel. This combined approach enhances the rate of conclusive biopsy and benefits from both visual assessment and radiological navigation. Results To date, 9 PBE procedures have been performed on 7 individual patients. Indications have included strictured hepaticojejunostomy, hepatolithiasis, malignant and benign biliary strictures. The first two patients underwent two-stage treatment of their disease following concerns about the burden of their treatment, however procedural intent was achieved in all cases. To date, two patients have experienced complications. The first required ITU admission for inotropic support in the context of a septic shower and the second suffered cholangitis secondary to a post-procedural haemorrhage and intraductal thrombus, requiring traditional internal/external drainage. Conclusion PBE, with its adjuncts, offers a minimally invasive alterative to operative treatment, and improved conclusive biopsy rates in patients with endoscopically inaccessible bile ducts due to post-surgical anatomy or impassable strictures. With appropriate multidisciplinary collaboration, PBE could easily be adopted in most hepatobiliary centres where the required equipment is likely to be readily available

Abstract 4127931: Chronic Steroid Use is Associated with Increased Readmission Rates in Patients Admitted with Acute Coronary Syndromes

Introduction: Acute coronary syndrome (ACS) is associated with significant morbidity and mortality. Management of ACS includes percutaneous coronary intervention (PCI) and requires the use of antithrombotic therapy, which increases bleeding risk. Chronic steroid use (CSU) is common for many diseases and is also associated with bleeding risk and impaired wound healing. However, data on outcomes of patients with CSU and AMI are sparse. Methods: Patients admitted for ACS and managed with PCI from 2014 to 2020 with and without CSU were identified using the National Readmissions Database (NRD). In-hospital outcomes include death, arterial thrombosis (composite of ischemic stroke and arterial thromboembolism), and major bleeding (composite of gastrointestinal, intracranial, or post-procedure bleeding or transfusion). Ninety-day readmission outcomes were cardiovascular (CV)-related, bleeding-related and all-cause. Multivariable logistic or Cox proportional hazards were utilized. Results: A total of 1,087,357 patients with ACS were included, of whom, 9,864 (0.9%) had CSU. After multivariable adjustment, there was no significant difference in in-hospital mortality (3.1% vs 3.2%; OR 1.09, 95% CI 0.93-1.26) or risk of arterial thrombosis (3.3% vs 2.8%; OR 0.91, 95% CI 0.81-1.02) between patients with and without CSU. CSU was associated with an increased risk of major bleeding events (8.3% vs 6.0%; OR 1.15, 95% CI 1.06-1.25). CSU was associated with a higher risk of CV-related (10.7% vs 7.5%; HR 1.10, 95% CI 1.02-1.18), bleeding-related (2.3% vs 1.2%; HR 1.28, 95% CI 1.09-1.51), and all-cause 90-day readmissions (23.9% vs 14.9%; HR 1.28, 95% CI, 1.22-1.34). Conclusion: Among patients admitted with ACS who underwent PCI, CSU was associated with increased risk of bleeding during index hospitalization and readmissions for bleeding. Furthermore, CSU was associated with increased risk of 90-day CV and all-cause readmission. Further studies are needed to better characterize this risk.

Abstract 4138788: Outcomes of Percutaneous Coronary Interventions Following Transcatheter Aortic Valve Replacement: Insights from the National Cardiovascular Data Registry (NCDR) CathPCI Registry

Background: Although transcatheter aortic valve replacement (TAVR) devices can impair coronary access, there are limited real-world data on rates of percutaneous coronary intervention (PCI) and PCI outcomes in post-TAVR patients. Research Question: How often do patients who undergo TAVR develop coronary events, and do they have different procedural characteristics or rates of adverse events when undergoing PCI compared to patients without a TAVR? Methods: We used CMS claims data for the Medicare fee-for-service population to evaluate the incidence of PCI after TAVR between 2011-2017. Then, using data from the NCDR CathPCI Registry linked with Medicare claims, we compared procedural characteristics and PCI outcomes between patients with a history of TAVR vs. propensity-matched patients who did not have a history of TAVR. Results: Of the 52,780 Medicare fee-for-service patients who underwent TAVR between 2011-2017, the incidence of acute myocardial infarction (AMI) was 10.6% and of PCI was 5.4% at five years. Among those patients, 5.6% had a PCI in the three months preceding their TAVR. After propensity-score matching, the procedural success rates for PCI were similar between patients with vs. without a history of TAVR. However, in the propensity-matched comparison, PCI in post-TAVR patients required greater fluoroscopic time (21.9 vs 17.7 mins, p&lt;0.001) and was associated with a greater incidence of post-procedural stroke (0.8% vs 0.4%, p=0.02) and bleeding (5.1% vs 2.9%, p &lt; 0.001). At three-year follow-up post-PCI, there were no differences in the rates of AMI between patients with vs. without a history of TAVR (HR: 1.22, 95% C.I.: 0.97, 1.54, p=0.08). However, patients with prior TAVR were more likely to have repeat PCI in the three years following their index procedure (HR: 1.38, 95% C.I.: 1.12, 1.73, p=0.003). Conclusion: Among Medicare fee-for-service patients, one in 20 patients undergoing TAVR subsequently underwent PCI within 5 years. Although the rates of procedural success were similar, patients with a history of TAVR who underwent PCI had longer fluoroscopic times, more frequent in-hospital adverse events, and a higher likelihood of a repeat PCI compared with matched patients without a history of TAVR.

Radiofrequency balloon ablation: 1-year outcomes of the AURORA study.

A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into a 3D mapping platform was recently launched. Patients undergoing a first atrial fibrillation (AF) ablation at two German high-volume EP centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180, and 360days following ablation including 48-h Holter ECGs. A total of 99 patients were enrolled (43/99 (43.4%) women, median age 67years (interquartile range [IQR] 59-74), 43/99 (43.4%) persistent AF (Pers-AF), median left ventricular ejection fraction (LVEF) 60% (IQR 62-55)). Eighty-eight patients completed the follow-up. Acute PVI was achieved in 383/383 (100%) PV. Single-shot PVI was achieved in 211/383 (55.1%) PVs. Primary adverse events occurred in 3% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke, or phrenic nerve paralysis was observed. Median ablation and procedure times were 23 (IQR 18-32) and 67 (IQR 57-85) min, respectively. Median dose area product was 761 (IQR 509-1534) mGycm2. AF-free survival after a median FU of 361 (IQR 261-375) days was 78.4% for paroxysmal AF (PAF) and 75.4% for Pers-AF (p value = 0.828). Early recurrence of atrial tachyarrhythmia at the 90-day visit was the only independent predictor for AF recurrence at 1year upon multiple regression analysis (hazard ratio [HR] 3.198; 95% confidence interval [95% CI] 1.036-10.32, p value = 0.0433). RFB-based PVI is acutely successful, appears safe, and has comparable rhythm outcomes to other single-shot AF ablation tools. A recurrence of AF at 90days predicts later AF recurrence.

Association between preprocedural thromboembolic or bleeding events under oral anticoagulation therapy and mid-term outcomes after percutaneous left atrial appendage closure

Abstract Background Currently, no consensus has been established on the most effective antithrombotic therapy to prevent thromboembolic and bleeding events in patients undergoing percutaneous left atrial appendage closure (LAAC). Methods We retrospectively investigated the incidence of device-related thrombosis (DRT), thromboembolic events, and bleeding events in patients who underwent LAAC from September 2019 to October 2022. After categorizing patients into groups based on preprocedural thromboembolic or bleeding events under oral anticoagulation (OAC) therapy, we compared the incidence of DRT and prognosis according to the postprocedural antithrombotic therapy. Results In patients who received the conventional antithrombotic therapy (OAC with and without single antiplatelet therapy for 45 days after LAAC and dual-antiplatelet therapy from 45 days to 6 months followed by single antiplatelet therapy), preprocedural thromboembolic events despite OAC were independently associated with DRT or postprocedural thromboembolic events at the 3-year follow-up (hazard ratio [HR] 4.55; 95% confidence interval [CI] 1.32–15.6; P = 0.016), whereas preprocedural bleeding events were independently associated with postprocedural bleeding events (HR 8.01, 95% CI 1.45–58.3; P = 0.036). Continuation of OAC for 12 months among patients who developed preprocedural thromboembolic events during OAC significantly decreased the incidence of DRT or postoperative thromboembolic events (P = 0.002) with no increase in the bleeding events (P = 0.522). Conclusions Preprocedural thromboembolic and bleeding events can predict adverse events after LAAC with conventional antiplatelet-based antithrombotic therapy. Patients who develop thromboembolic events under continuous OAC may benefit from continuous OAC for 1 year after LAAC.

Safety and Efficacy of Endoscopic Submucosal Dissection for Rectal Neoplasms Extending to the Dentate Line: A Systematic Review and Meta-analysis.

Endoscopic submucosal dissection (ESD) is a superior, minimally invasive technique compared with other snare-based endoscopic resection techniques for rectal neoplasms extending to the dentate line (RNDLs). However, performing a successful ESD in the anal canal can be challenging due to vascularity and limited scope stability. In this meta-analysis, we aim to evaluate the safety and efficacy of ESD for RNDLs. We performed a comprehensive electronic database search from January 2005 through January 2024 for studies evaluating outcomes of ESD performed for managing RNDLs. Pooled proportions were calculated using random-effect models. Heterogeneity was evaluated using I2 and Q statistics. Data were extracted from 11 studies comprising 496 patients. The pooled en bloc resection rates were 93.60% (95% CI = 90.70-95.70). The pooled R0 resection rate was 80.60% (95% CI = 70.50-87.80). The pooled recurrence rate was 4.00% (95% CI = 2.40-6.50). There was no evidence of significant heterogeneity calculated using the Q test and I2 statistic. The main adverse events were anal pain, postprocedural bleeding, and anal stricture with pooled rates of 20.20% (95% CI = 14.80-26.90), 8.20% (95% CI = 4.70-14.0), and 3.50% (95% CI = 2.10-5.70), respectively. ESD is a safe and effective option for managing RNDLs with a low recurrence rate. Adverse events such as postprocedural perianal pain, postprocedural bleeding, and anal stenosis seem to be more common compared with colorectal ESD done for more proximal lesions. However, these can typically be managed conservatively or with minimally invasive endoscopic techniques.

Comprehensive analysis of the impact of procedure time and the ‘golden hour’ in subpopulations of stroke thrombectomy patients

ObjectiveTo evaluate the effect of procedure time on thrombectomy outcomes in different subpopulations of patients undergoing endovascular thrombectomy (EVT), given the recently expanded indications for EVT.MethodsThis multicenter study included patients...

Optimal diameter of endoscopic dilatation in anastomotic stricture after esophagectomy.

The optimal diameter for endoscopic dilatation of anastomotic strictures after esophagectomy has not been elucidated. This study aimed to determine the optimal target diameter for endoscopic dilatation for anastomotic stricture after esophagectomy. The medical records of patients who underwent endoscopic dilatation for anastomotic stricture after esophagectomy between January 2009 and June 2024 at Pusan National University Yangsan Hospital were reviewed. The stricture recurrence rate, dilatation-free period, and complications according to the dilatation diameter were collected and included in the analysis. We analyzed 149 endoscopic dilatations (diameters from 10 to 18mm) in 43 patients. The median follow-up period was 47months (range, 5-157). The stricture recurrence rate was 72.5%, and the median dilatation-free period was 60days. The stricture recurrence rate was the lowest (41.7%, p = 0.022), and the overall dilatation-free period was the longest (median 490days, p = 0.171) in dilations up to 16.5mm. The stricture recurrence rate was higher in dilations up to 18mm than in those up to 16.5mm (54.5% vs. 41.7%, p = 0.331). Moreover, the bleeding rate was higher in patients with dilations up to 18mm (18.2% vs. 4.2%, p = 0.205). In patients with anastomotic strictures after esophagectomy, dilation up to 16.5mm showed a lower stricture recurrence rate, longer dilation-free period, and less postprocedural bleeding than those of dilation up to 18mm.

Rates and risk factors of bleeding after gastric endoscopic submucosal dissection with continuous warfarin or 1-day withdrawal of direct oral anticoagulants.

The 2017 Japanese guidelines recommend continuing warfarin therapy during the perioperative period or discontinuing direct oral anticoagulants (DOACs) only on the day of endoscopic submucosal dissection for early gastric cancer. However, their safety has not been sufficiently explored. This study aimed to validate this management method. This retrospective, multicenter study analyzed the characteristics and outcomes of patients who underwent gastric endoscopic submucosal dissection between July 2017 and June 2019. The patients were categorized according to the use of warfarin or DOACs. Among the 62 eligible patients, 53 (85%) were male (median age, 76years). Warfarin was used in 10 patients (16%) and DOACs in 52 patients (84%). Fourteen patients taking DOACs (27%) used concomitant antiplatelet agents, with seven patients (13%) continuing treatment at the time of the endoscopic procedure. No postprocedural bleeding occurred in patients receiving warfarin (0%), whereas 10 cases (19%) of bleeding occurred in patients receiving DOACs: rivaroxaban, 0% (0/22); dabigatran, 0% (0/2); edoxaban, 43% (6/14); and apixaban, 29% (4/14). The type of anticoagulant (P<0.01) and continuation of antiplatelet therapy (P=0.02) were risk factors for postprocedural bleeding in patients receiving DOACs. Intraprocedural bleeding requiring transfusion or symptomatic thromboembolic events were not reported. Continuous warfarin therapy is preferred. DOAC withdrawal 1day before a procedure is associated with a high bleeding rate, which may differ for different types of anticoagulants. The continuation of antiplatelet medications in patients receiving DOACs carries a high risk of bleeding and is a future challenge.

TCT-631 Outcomes in Patients With Major Postprocedural Bleeding After Transcatheter Edge-to-Edge Repair of the Mitral Valve

TCT-631 Outcomes in Patients With Major Postprocedural Bleeding After Transcatheter Edge-to-Edge Repair of the Mitral Valve

Efficacy and safety of the over-the-scope endoscopic suturing device for closure of defects after endoscopic submucosal dissection: a systematic review and meta-analysis

Background and AimsEndoscopic submucosal dissection (ESD) is used for closure of gastrointestinal (GI) lesions following endoscopic resection techniques such as endoscopic mucosal resection. Generally, a large defect is left that can increase the risk of postprocedural bleeding or perforation, and has been managed by techniques such as endoscopic placement of clips to reapproximate the defect edges. An over the scope suturing system (OSS), Overstitch created by Apollo endosurgery, has been designed for similar utility in ESD closure. Its design intent aimed for full thickness closure and exchange of suture without endoscopic removal. This paper aims to evaluate the technical success and efficacy of use of OSS in the closure of ESD. MethodsA comprehensive literature review across multiple databases was performed. Studies including Overstitch and ESD information were evaluated, with 7 articles meeting predetermined eligibility of quality for inclusion. Statistical analysis was completed using CMV v 3.0 software. The primary evaluated endpoint was technical success and efficacy of instrument use in patients undergoing ESD closure with OSS. The secondary evaluated endpoint was the overall rate of adverse events related to the use of OSS. ResultsOverall, the pooled rates for instrumental efficacy and technical success were 95.8% (95% CI: 80.6%, 99.2%; P=0.04) and 99.2% (95% CI: 79.8%, 100.0%; P=1.00), respectively. The pooled rate of adverse events was 0.9% (95% CI: 0.0%, 24.8%; P=0.99) with pain reported as the most common adverse event. ConclusionsThe OSS system appears to be an effective and safe tool in the closure of defects after ESD. However, its design also makes it quite large and difficult to maneuver. While it allows for replacement of the suture kit without endoscopic removal, there have been multiple reported episodes of device failure. Further randomized controlled trials warranted as OSS becomes more widely used.

Minimally-invasive tracheostomy (MIT): A care bundle for safety improvement in high-risk critically ill patients

BackgroundDetailed reports are scarce on minimally-invasive tracheostomy (MIT) techniques for critically ill patients with challenging anatomy or complex coagulopathies. In such high-risk patients, conventional percutaneous dilatational tracheostomy (PDT) may lead to severe complications. MethodsAiming to broaden the scope of MIT for patients previously excluded due to high risks, we developed a new care bundle (MIT technique), specifically designed for intensive care specialists. Our study examined the outcomes of MIT in 32 high-risk patients treated in an ICU of a University Hospital with specific focus on gastrointestinal and liver diseases. ResultsWe have modified the conventional PDT technique by incorporating an initial skin incision, blunt dissection, diaphanoscopy-guided probe puncture, and continuous bronchoscopic monitoring. Our care bundle also introduces an anterolateral approach for tracheal entry, a significant advancement for patients with complex neck anatomy or dense vasculature, where an anterolateral trajectory avoids midline blood vessels. This enhanced method has proven to be safer than traditional PDT, with a notable absence of post-procedural hemorrhages, cannula misplacements, or infections. ConclusionThe use of our refined care bundle enabled swift minimally-invasive tracheostomy in high-risk patients without the occurrence of serious complications.

Dynamics of Thrombogenicity and Platelet Function and Correlation with Bleeding Risk in Patients Undergoing M-TEER Using the PASCAL System.

Transcatheter mitral valve repair is performed in a patient population at risk for thrombotic and bleeding events. The effects on platelet function and reactivity and their association with bleeding events after mitral transcatheter edge-to-edge therapy (M-TEER) have not been systematically examined. We sought to investigate the association of different parameters of platelet function and thrombogenicity with bleeding events post M-TEER. In this single-center study, 100 consecutive patients with mitral regurgitation receiving TEER were analyzed. Blood was taken directly from the guide-catheter in the left atrium before and after placing the device. Blood samples were analyzed using impedance aggregometry (Multiplate) and TEG6s. The results were compared pre- and postprocedural. The primary outcome was any bleeding complication according to the Bleeding Academic Research Consortium classification within 6 months. A total of 41 patients experienced bleeding events. TEG analysis showed a significant decrease in ADP aggregation and increase in ADP inhibition. In ROC-analysis, TEG ADP aggregation and inhibition and Multiplate ADP aggregation showed moderate predictive values for bleeding events. The delta-ADP-Test (Multiplate) showed the strongest prediction of bleeding (area under the curve: 0.69). Adding platelet function and TEG markers to a model of clinical bleeding risk factors improved the prediction for bleeding events. This study indicates that thrombogenicity might be affected immediately after M-TEER probably due to changes in flow conditions. In particular, platelet aggregation involving the ADP receptor pathway significantly correlated with postprocedural bleeding events. Whether these results could guide peri-interventional antithrombotic therapy and improve peri- and postprocedural outcome requires further investigation.

Investigating clinical decision-making in bleeding complications among nursing students: A longitudinal mixed-methods study

AimTo describe undergraduate nursing students’ clinical decision-making in post-procedural bleeding scenarios and explore the changes from the first to the final year of their program. BackgroundBleeding is a common complication following invasive procedures and its effective management requires nurses to develop strong clinical decision-making competencies. Although nursing education programs typically address bleeding complications, there is a gap in understanding how nursing students make clinical decisions regarding these scenarios. Additionally, little is known about how their approach to bleeding management evolves over the course of their education. DesignLongitudinal mixed-methods study based on the Recognition-Primed Decision Model. MethodsA total of 59 undergraduate students recorded their responses to two clinical decision-making vignettes depicting patients with signs of bleeding post-hip surgery (first year) and cardiac catheterization (final year). Their responses were analyzed using content analysis. The resulting categories capture the cues students noticed, the goals they aimed to achieve, the actions they proposed and their expectations for how the bleeding situations might unfold. Code frequencies showing the most variation between the first and final years were analyzed to explore changes in students’ clinical decision-making. ResultsNearly all students focused on two primary categories: ‘Bleeding’ and ‘Instability and Shock.’ Fewer students addressed six secondary categories: ‘Stress and Concern,’ ‘Pain,’ ‘Lifestyle and Social History,’ ‘Wound Infection,’ ‘Arrhythmia,’ and ‘Generalities in Surgery.’ Students often concentrated on actions to manage bleeding without further assessing its causes. Changes from the first to the final year included a more focused assessment of instability and shifts in preferred actions. ConclusionsThis study reveals that nursing students often prioritize immediate actions to stop bleeding while sometimes overlooking the assessment of underlying causes or broader care goals. It suggests that concept-based learning and reflection on long-term outcomes could improve clinical decision-making in post-procedural care.

Hepatic and splenic venous access tract closure using the VASCADE vascular closure system following percutaneous intervention in patients with CHD.

Hepatic and splenic venous access are specialised techniques used to perform diagnostic and interventional procedures in the cardiac catheterisation laboratory. Bleeding events are the most commonly reported complication following hepatic or splenic venous access. The VASCADE Vascular Closure System (Cardiva Medical Inc. Santa Barbara, CA) is an approved device for closure of femoral vascular access tracts in patients ≥18 years of age. We report our experience using VASCADE to close the hepatic or splenic venous access site in the cardiac catheterisation laboratory. This is a single centre retrospective review of all patients who had percutaneous hepatic or splenic venous access obtained in the cardiac catheterisation laboratory from March 1, 2022 through October 30, 2023 and underwent tract closure with VASCADE. Ten patients (six male) underwent 16 procedures (median age and weight 3.5 years and 12.5 kg) with 15 hepatic and two splenic veins accessed. Successful closure of the access tracts with VASCADE was performed in all patients. There were no major adverse events related to closure of the access sites with VASCADE. VASCADE can be used following transhepatic and trans-splenic venous access in the cardiac catheterisation laboratory to safely close the access tract and potentially reduce the risk of post-procedural bleeding complications. Further evaluation in a larger cohort of patients is needed to ensure VASCADE is safe for use and provides adequate haemostasis following hepatic or splenic venous access, particularly in children.

[89Zr]Zr-girentuximab for PET–CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial

With limitations of conventional imaging and biopsy, accurate, non-invasive techniques to detect clear-cell renal cell carcinoma in patients with renal masses remain an unmet need. 89Zr-labelled monoclonal antibody ([89Zr]Zr-girentuximab) has high affinity for carbonic anhydrase 9, a tumour antigen highly expressed in clear-cell renal cell carcinoma. We aimed to evaluate [89Zr]Zr-girentuximab PET-CT imaging for detection and characterisation of clear-cell renal cell carcinoma. ZIRCON was a prospective, open-label, multicentre, phase 3 trial conducted at 36 research hospitals and practices across nine countries (the USA, Australia, Canada, the UK, Türkiye, Belgium, the Netherlands, Spain, and France). Patients aged 18 years or older with an indeterminate renal mass 7 cm or smaller (cT1) suspicious for clear-cell renal cell carcinoma and scheduled for nephrectomy received a single dose of [89Zr]Zr-girentuximab (37 MBq ±10%; 10 mg girentuximab) intravenously followed by abdominal PET-CT imaging 5 days (±2 days) later. Surgery was performed no later than 90 days after administration of [89Zr]Zr-girentuximab. Blinded central review, conducted by three independent readers, determined the histology from surgical samples. The coprimary endpoints, determined for each individual reader, were the sensitivity and specificity of [89Zr]Zr-girentuximab PET-CT imaging to detect clear-cell renal cell carcinoma, with histopathological confirmation as standard of truth. Analyses were on the full analysis set of patients, defined as patients who had evaluable PET-CT imaging and a confirmed histopathological diagnosis. The trial is registered with ClinicalTrials.gov, NCT03849118, and EUDRA Clinical Trials Register, 2018-002773-21, and is closed to enrolment. Between Aug 14, 2019, and July 8, 2022, 371 patients were screened for eligibility, 332 of whom were enrolled. 300 patients received [89Zr]Zr-girentuximab (214 [71%] male and 86 [29%] female). 284 (95%) evaluable patients were included in the primary analysis. The mean sensitivity was 85·5% (95% CI 81·5-89·6) and mean specificity was 87·0% (81·0-93·1). No safety signals were observed. Most adverse events were not or were unlikely to be related to [89Zr]Zr-girentuximab, with most (193 [74%] of 261 events) occurring during or after surgery. The most common grade 3 or worse adverse events were post-procedural haemorrhage (in six [2%] of 261 patients), urinary retention (three [1%]), and hypertension (three [1%]). In 25 (8%) of 300 patients, 52 serious adverse events were reported, of which 51 (98%) occurred after surgery. There were no treatment-related deaths. Our results suggest that [89Zr]Zr-girentuximab PET-CT has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of clear-cell renal cell carcinoma, which has the potential to be practice changing. Telix Pharmaceuticals.

789. EFFICACY AND SAFETY OF CRYOBALLOON-180 ABLATION FOR THE TREATMENT OF DYSPLASTIC BARRETT ESOPHAGUS: PRELIMINARY RESULTS FROM A PROSPECTIVE MULTICENTER STUDY

Abstract Background Cryoballoon-ablation is a relatively novel method for the eradication of dysplastic Barrett esophagus (BE). While the focal cryoballoon-ablation system has shown to be efficacious for BE of limited extent, the cryoballoon180-ablation system (CBAS180) is developed to treat longer BE segments by semi-circumferential ablation over 3cm, in a single step. A first-in-human study demonstrated the feasibility of CBAS180 treatment, yet the optimal dose needs to be determined. The current prospective, multicenter study, investigates CBAS180 at lower dosages for patients with dysplastic BE. Methods A total of 62 patients with ablation naïve BE (C≤3 and M≥1) will be enrolled in six Dutch Barrett expert centers. Treatment consists of a full circumferential ablation over 3 cm of length, using two semi-circumferential ablations at a dose of 1.2 mm/sec. Follow-up consisted of phone calls at days 1, 7 and 30, a symptom diary during 14 days, and an endoscopy after 3 months. Outcomes included (1) technical success rate; (2) BE regression percentage at follow-up scored by an independent adjudication committee; (3) incidence of adverse events; (4) post-procedural pain (scored on a scale of 0-10); and (5) post-procedural dysphagia (scored on a validated scale of 0-4). Follow-up treatment consisted of focal cryoballoon-ablation until complete eradication of visible BE was achieved, confirmed by biopsies from the neo-Z-line. Results So far, 25 patients (80% male; mean age 67) with a median BE length of C0M2 (p25-p75 C0-1M2-4) were included. Technical success rate was 92% (23/25; 95% CI 74-99%). In two patients, treatment was technically unsuccessful due to unstable positioning of the balloon (n=1) or a device malfunction (n=1). Median procedure time was 14 (p25-p75 11-16) 4) minutes and median ablation time was 5 (p25-p75 3-5) minutes. All 23 successfully treated patients completed follow-up endoscopy at 3 months. Median BE regression was 90% (p25-p75 75%-100%) evaluated by the independent adjudication committee. Overall, CBAS180 adverse event rate was 8% (2/23); one patient developed esophageal stricture (1/23; 4% [95% CI 1-16%]) resolved after a single endoscopic dilation. Another patient (1/23; 4% [95% CI 1-16%]) experienced post-procedural bleeding, with re-endoscopy without intervention. The CBAS180 procedure was well tolerated with low post-procedural pain (median 2 [p25-p75 1-4] at day 1 and 0 [p25-p75 0-1] at day 7) and dysphagia (56% and 70% of patients with score 0 at days 1 and 7, respectively) scores. So far, 22/23 (95%) patients were additionally treated with focal cryoballoon-ablation and 18/22 (82%) achieved a complete endoscopis and histologic eradication of BE after median 1 (p25-p75 1-3) treatment, the other 4 are still under treatment. After focal cryoballoon-ablation, 2/22 patients developed strictures, resolved after 1 and 2 endoscopic dilatations. Conclusion Based on these preliminary results, circumferential ablation with CBAS180 at 1.2 mm/sec, followed by focal cryoballoon-ablation, emerges as an effective and safe procedure for dysplastic BE eradication in the hands of expert endoscopists. Further avenues for exploration should encompass the assessment of multiple CBAS180 ablations stacked on top of each other in larger segments and the validation of outcomes in a larger patient cohort.